MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 2; HIP STEM CEMENTLESS

Model Number	01.18.412
Medical Device Problem Code	Failure to Osseointegrate (1863)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 19-jul-2022.Lot 2010559: 55 items manufactured and released on 05-jan-2021.Expiration date: 2025-12-16.No anomalies found related to the problem.To date, 31 items of the same lot have been sold with no similar reported case during the period of review.Clinical evaluation: revision 1 year after index surgery in a 71 year old male patient due to stem loosening.No information concerning patient general health status and the presence of comorbidities is available.Only one radiograph is available and we assume it is the pre-revision image.There seems to be little or no contact between bone and stem, at least in this view.The stem couls have been undersized at index surgery or it could have reabsorbed for unknown reasons.The report says no infection is present but we are not sure that this is the result of a thorough analysis, given the date of the event which coincides with the date of the report.The reason of this failure cannot be fully determined.
Event or Problem Description
At about 1 year after the primary surgery, an hip revision surgery on the right side was performed due to stem loosening.No acetabular loosening and no infection detected.The surgery was completed successfully.

• Brand Name: STEM: AMISTEM P AMISTEM-P LAT STEM SIZE 2
• Common Device Name: HIP STEM CEMENTLESS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 15217367
• Report Number: 3005180920-2022-00606
• Device Sequence Number: 5746305
• Product Code: LZO
• UDI-Device Identifier: 07630040720113
• UDI-Public: 07630040720113
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K173794
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/16/2025
• Device Model Number: 01.18.412
• Device Catalogue Number: 01.18.412
• Device Lot Number: 2010559
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 76 KG